Adaptive CRT optimization at rest and during exercise

Withdrawn

Conditions: heartfailure
resynchronisation therapy
10019280

Registration Number: NL-OMON37566

Lead Sponsor: Medtronic Trading NL BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

* 18 or greater.
* sign and date study Informed Consent form.
* Subject implanted with a clinically indicated CRT-D device (Medtronic Vision 3D or Protecta models) for at least 1 month but less than 7 months

Exclusion Criteria

* history of persistent or permanent AF
* atrial or ventricular tachyarrhythmias or frequent atrial or ventricular ectopy at the time of enrollment.
* resting heart rate at the time of enrollment exceeds 90 bpm.
* CRT system implanted for more than 7 months
* complete AV block.
* previous mechanical valve surgeries.
* congenital heart disease.
* contraindication for an exercise test.
* unable to perform a sub-maximal exercise test.
* It is not possible to acquire technically acceptable echocardiographic images.
* medical conditions that would limit study participation.
* Subject is enrolled in the Adaptive CRT study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Compare Stroke Volume (SV) between BiV pacing with aCRT settings and BiV with<br /><br>nominal programming. The comparison will be performed at rest and during<br /><br>submaximal exercise.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Compare Blood Pressure-derived (Pulse Pressure and Stroke Volume) and<br /><br>ECHO-derived (Left-Ventricular Ejection Fraction, Left-Ventricular Pre-ejection<br /><br>Interval and Ejection Time) parameters of cardiac function between BiV pacing<br /><br>with aCRT settings and BiV with nominal settings. The comparison will be<br /><br>performed during resting rate and during submaximal exercise.<br /><br><br /><br>* Compare Blood Pressure-derived (Pulse Pressure and Stroke Volume) and<br /><br>ECHO-derived (Left-Ventricular Ejection Fraction, Left-Ventricular Pre-ejection<br /><br>Interval and Ejection Time) parameters of cardiac function between BiV pacing<br /><br>and intrinsic conduction at rest and during submaximal<br /><br>exercise.<br /><br><br /><br>* Investigate changes in electrical conduction during submaximal exercise.</p><br>